No axillary surgical treatment for lymph node-negative patients after ultra-sonography [NAUTILUS]: protocol of a prospective randomized clinical trial

Ji Gwang Jung; Se Hyun Ahn; Seeyoun Lee; Eun-Kyu Kim; Jai Min Ryu; Seho Park; Woosung Lim; Yong Sik Jung; Il Yong Chung; Joon Jeong; Ji Hyun Chang; Kyung Hwan Shin; Jung Min Chang; Woo Kyung Moon; Wonshik Han

doi:10.1186/s12885-022-09273-1

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No axillary surgical treatment for lymph node-negative patients after ultra-sonography [NAUTILUS]: protocol of a prospective randomized clinical trial

Authors: Ji Gwang Jung ; Se Hyun Ahn ; Seeyoun Lee ; Eun-Kyu Kim ; Jai Min Ryu ; Seho Park ; Woosung Lim ; Yong Sik Jung ; Il Yong Chung ; Joon Jeong ; Ji Hyun Chang ; Kyung Hwan Shin ; Jung Min Chang ; Woo Kyung Moon ; Wonshik Han

Citation: BMC CANCER, Vol.22(1) : 189, 2022-02

Journal Title: BMC CANCER

Issue Date: 2022-02

MeSH: Adult ; Axilla / diagnostic imaging ; Axilla / pathology ; Breast Neoplasms / diagnostic imaging* ; Breast Neoplasms / pathology ; Breast Neoplasms / surgery ; Female ; Humans ; Lymph Node Excision* ; Lymph Nodes / diagnostic imaging ; Lymph Nodes / pathology ; Lymphatic Metastasis / diagnostic imaging* ; Mastectomy, Segmental ; Patient Selection ; Prospective Studies ; Randomized Controlled Trials as Topic ; Sentinel Lymph Node Biopsy / statistics & numerical data* ; Ultrasonography* ; Young Adult

Keywords: Breast cancer ; Sentinel node biopsy ; Ultrasound

Abstract: Background: Following sentinel lymph node biopsy (SLNB), the axillary recurrence rate is very low although SLNB has a false-negative rate of 5-10%. In the ACOSOG Z0011 trial, non-sentinel positive-lymph nodes were found in more than 20% of the axillary dissection group; the SLNB only group did not have a higher axillary recurrence rate. These findings raised questions about the direct therapeutic effect of the SLNB. SLNB has post-surgical complications including lymphedema. Considering advances in imaging modalities and adjuvant therapies, the role of SLNB in early breast cancer needs to be re-evaluated.

Methods: The NAUTILUS trial is a prospective multicenter randomized controlled trial involving clinical stage T1-2 and N0 breast cancer patients receiving breast-conserving surgery. Axillary ultrasound is mandatory before surgery with predefined imaging criteria for inclusion. Ultrasound-guided core needle biopsy or needle aspiration of a suspicious node is allowed. Patients will be randomized (1:1) into the no-SLNB (test) and SLNB (control) groups. A total of 1734 patients are needed, considering a 5% non-inferiority margin, 5% significance level, 80% statistical power, and 10% dropout rate. All patients in the two groups will receive ipsilateral whole-breast radiation according to a predefined protocol. The primary endpoint of this trial is the 5-year invasive disease-free survival. The secondary endpoints are overall survival, distant metastasis-free survival, axillary recurrence rate, and quality of life of the patients.

Discussion: This trial will provide important evidence on the oncological safety of the omission of SLNB for early breast cancer patients undergoing breast-conserving surgery and receiving whole-breast radiation, especially when the axillary lymph node is not suspicious during preoperative axillary ultrasound.

Trial registration: ClinicalTrials.gov, NCT04303715 . Registered on March 11, 2020.